# K961063: AS/3 Cardiac Output & SVO2 Module

- Pathway: 510(k) (Traditional)
- Applicant: Datex Medical Instrumentation, Inc.
- Decided: May 31, 1996 after 74 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K052977: Datex-Ohmeda S/5 Cardiac Output and SVO2 Module, E-Copsv and Accessories (2005), 0 descendants of its own

## Indications for use
The AS/3™ COPSv module is intended to be used in the Datex AS/3™ Anaesthesia Monitor or in the AS/3™ Compact Monitor in anesthesia department, in intensive care department etc.

Source page: https://510kreport.com/device/K961063
Methodology: https://510kreport.com/methodology